It appears we never grow too old for a visit from the North Pole. “So, Louis,” a well-rounded Santa Claus in red dress and cheeks says through an unsettling wry smile. “Has your drug development and manufacturing outsourcing sector been good this year?” Here’s how I replied …
Through a grant from ACGT, one Cancer immunologist is offering T cell therapy to patients in desperate circumstances. The women enrolling in this trial have advanced ovarian cancer and have gone through at least two rounds of chemotherapy that haven’t worked.
Biocompatibility is an essential element for any pharmaceutical combination product. ISO 10993 is the standard for biocompatibility, and it is broken into various normative sub-standards from ISO10993-1 to -22 that focus on various assessments, considerations, recommendations, and approaches.
Principles and Practices for Medical Device Cybersecurity is intended to help facilitate international regulatory convergence on medical device cybersecurity by explaining fundamental concepts, best practices, and recommendations for all stakeholders.
With minimal specific guidance on commercial manufacturing from the FDA and a lack of robust platform commercial processes, some of the finer details of cell and therapy manufacturing can make operating companies feel like they are walking on a precarious limb.
This article lays out considerations and a process for developing user specifications when developing a new medical device. It is the first in a series that examines – and prioritizes -- necessary documentation when creating early an proof-of-concept prototype.
Process characterization is the foundation for process validation activities. Too often, validation activities fail due to the lack of process characterization using sound statistical and scientific methods, including design of experiments (DOE).
HR changes continually impact overall data integrity—from a single new hire to a corporate-level change with a merger or acquisition. It's a commonly overlooked weak link in the data integrity chain.
There are situations we have come across where we really scratch our heads and say, “What did they just do, and what were they thinking?” This article describes a series of events and activities that we have seen that are at once amusing, baffling, and revealing of the flaws in our industry.
The transfer of mAb production processes between scales, referred to as scale-up or scale-down, is difficult. This study reviews moving mAb production from a microscale bioreactor to a single-use platform.
Understand the strategies which can be employed at the different stages of development when choosing parenteral dosage forms.
When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices — choices that can be conflicting or present differing advantages.
This paper includes a discussion on vaccine processes, followed by a case study on the scale-up of upstream and downstream processes for the production of a cell-based live attenuated influenza virus using single-use ReadyToProcess technology.
This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.
When it comes to clinical supplies, the journey is every bit as important as the destination and the price of failure is high. This paper discusses how supply logistics are changing and contains examples of how Fisher Clinical Services is deploying flexible solutions to ensure secure, efficient and cost-effective passage of clinical supplies.
Starting with the editorial, What If Our Generics Strategy Has Been All Wrong?, Outsourced Pharma Chief Editor Louis Garguilo presents this series exploring the subjects of patents and pricing, innovative drugs versus generics, and our entire healthcare system. Learn more in this free collection of articles.
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